GUEST COLUMNISTS

  • 5 Recommendations To Maximize CSV/CSA Outcomes

    The computer system validation (CSV)/computer system assurance (CSA) process is correlated with other departments besides IT and quality. Accordingly, all stakeholders must think ahead and define what they need.

  • How Eli Lilly's Making Peptides Faster And More Reliably

    Three company leaders answer questions about the IE2b project, which is receiving an ISPE 2024 Facility of the Year Award for its ingenuity of complexity.

  • Bacterial Endotoxin Testing, Part 1: Overview

    All injectable drug products and implantable medical devices that come into contact with the bloodstream or spinal fluid are tested for endotoxins. This article provides an overview of bacterial endotoxin testing and the LAL method.

  • More Case Studies: Managing Change In Vaccine Production

    Part two of this series digs into real-world examples from Sanofi for getting the right stakeholders on board when altering a process or changing equipment.

  • June 2024 — CDMO Opportunities And Threats Report

    Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.

  • Correct But Misleading: AI Hallucinations In Complex Decision-Making

    Managing risks associated with AI hallucinations requires "explainability," a process that identifies patterns or behaviors in AI models that are inconsistent with training data or logical expectations. Regulators are mandating transparency in AI models used for drug testing and development.

  • End-To-End mRNA DS And DP Manufacturing Processes

    This article demystifies the manufacture of mRNA encapsulated in lipid nanoparticles across unit operations for plasmid linearization, drug substance (DS) manufacture, and drug product (DP) manufacture.

  • Why Knowledge Workers Must Embrace Standard Work

    Highly educated scientists often resist the notion of standard work because it seems stifling. On the contrary, standard work can increase productivity and creativity.

PHARMA OUTSOURCING WHITE PAPERS

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CONTENT COLLECTIONS

2024 CDMO Leadership Awards

 

A great resource to help you find and evaluate the best CDMOs in the world. Included in this CDMO Leadership Awards issue are some insightful articles on development and manufacturing outsourcing.

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